Important!
Use blank fields for those fields that are included in the CDUS standard but not used by the CTRP.
COLLECTIONS,<Study_Identifier>,,,,,,,,,<Change_Code> PATIENTS,<Study_Identifier>,<Study_Subject_Identifier>,<Zip_Code>,<Country_Code>,<Birth_Date>,<Gender>,<Ethnicity>,<Payment_Method>,<Subject_Registration_Date>,<Registering_Group_Identifier>,<Study_Site_Identifier>,,,,,,,,,,<Subject_Disease_Code>,, PATIENT_RACES,<Study_Identifier>,<Study_Subject_Identifier>,<Race>
The following is an example batch file for a study that has three study subjects, and one race per subject using CTRP accepted valid values. In the example below "Male", for example, is used instead of a CDUS accepted numeric value of "1".
COLLECTIONS,"NCI-2011-03861",,,,,,,,,1 PATIENTS,"NCI-2011-03861",873222899999999,84124,,196311,Male,Unknown,Private Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,, PATIENTS,"NCI-2011-03861",8732228,84124,,196311,Male,Unknown,Private Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,, PATIENTS,"NCI-2011-03861",1,84124,,196311,Male,Unknown,Private Insurance,20060809,CALGB,149280,,,,,,,,,,185.0,, "PATIENT_RACES","NCI-2011-03861",8732228,White "PATIENT_RACES","NCI-2011-03861",873222899999999,Asian "PATIENT_RACES","NCI-2011-03861",1,White
The following is another example batch file, accepted by CTRP, for the same study but using CDUS accepted numeric codes instead of the text values used in the example above .
COLLECTIONS,"NCI-2011-03861",,,,,,,,,1 PATIENTS,"NCI-2011-03861",873222899999999,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,238.7,, PATIENTS,"NCI-2011-03861",8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,238.7,, PATIENTS,"NCI-2011-03861",1,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,185.0,, "PATIENT_RACES","NCI-2011-03861",8732228,01 "PATIENT_RACES","NCI-2011-03861",873222899999999,05 "PATIENT_RACES","NCI-2011-03861",1,01
Special Characters
If you include any of the following characters in a value, enclose the field with double quotes:
! " # $ % & ' ( ) * + , - . / : ; < > = ? @ [] \^ _{} | ~
If you enclose a field with double quotes (as in "NCI-2012-00225"), CTRP interprets the string inside the quote exactly as presented. If the field does not contain any special characters, the quote marks are optional.
ICD-O-3 Trial Format for Topography Codes
C64.9;8000/3
Examples:
PATIENTS,"NCI-2011-03861",8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,238.7,,
PATIENTS,"NCI-2011-03861",8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,C64.9;8000/3,,